Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material

University of Rochester

Status

Completed

Conditions

Dental Caries

Restorative Material

Treatments

Device: TPH3

Device: urethane dimethacrylate

Device: Esthet-X HD

Study type

Interventional

Funder types

Other

Identifiers

NCT02018822

765-552

Details and patient eligibility

About

This double blind randomized controlled prospective clinical trial will compare the clinical success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk) and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the posterior restorations for 24 months in duration

Full description

The purposes of this clinical trial is to evaluate two composite resins used to restore Class I and Class II cavities in teeth of adults. The clinical study will evaluate the resin composite restorations placed in Class I and Class II cavity preparations for anatomic form, color match, marginal integrity, marginal discoloration, proximal contact, polishability, caries, sensitivity, gingival index, staining,wear, and thermal response for 24 months..

Enrollment

85 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• must have given written consent to participate in the trial

must be in need of at least two restorations in natural tooth
replacement restorations with or without caries are acceptable
must be available for the required post-operative follow-up visits
restorations to be in bicuspids, 1st or 2nd molars
restorations to be in contact with opposing natural or crowned teeth
class II restorations must have at least one proximal contact
restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
75% of the restorations must be Class II
all restorations must have at least one occlusal contact in habitual closure

Exclusion Criteria:

have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) or disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
have a history of chronic bruxism and those unavailable for long term recall
can not tolerate the rubber dam required for tooth isolation during preparation and restoration.
do not meet all inclusion criteria
present with any systemic or local disorders that contra-indicate the dental procedures included in this study
have an unstable occlusion
have severe bruxing or clenching or need of TMJ related therapy
have teeth with periapical pathology or expected pulp exposures
have teeth that are non-vital or that exhibit signs of pulpal pathology
Pregnancy
Known sensitivity to methacrylates and/or acrylates